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U.S. Department of Health and Human Services


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Drug Safety

Below is a sortable table of Drug Safety Guidances


Note:Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review (PDF - 1516KB)

This guidance has been superseded by

Attachment B: Clinical Safety Review of an NDA or BLA of the Good Review Practice: Clinical Review Template (MAPP 6010.3 Rev. 1) that was posted on Dec 15, 2010